GCP Training & Capacity-Building Workshops

GCP Training & Capacity-Building Workshops

Design and delivery of Good Clinical Practice (GCP) training programs for investigators, coordinators, and site staff. GCP training fosters a compliance culture, as mandated by ICH GCP 2.9 (Personnel Qualifications) and ICMR Section 12 (Training Requirements). Our workshops equip teams with practical skills for NDCT-compliant trials, using interactive formats to enhance retention and application. We specialize in cooperating with pharmaceutical, biotechnology, and medical device companies to conduct clinical research trials, integrate speedy patient enrollment solutions into clinical trials, and rescue delayed clinical trials/FDA submissions. We offer world-class results in both quality and speed of enrollment. Shree Clinical Research's SOPs meet the highest standards for conducting clinical trials.
GCP Training & Capacity-Building Workshops

Practical Guidelines and Support

Core Curriculum

Cover ICH GCP principles (e.g., risk-based quality, 1.64), roles (4.1-4.13), informed consent (4.8), SAE reporting (4.11), and audit prep (5.19), plus ICMR specifics on equity and vulnerability (Sections 6-8).

Delivery Methods

8-16 hour sessions with lectures, case studies (e.g., deviation scenarios per NDCT Rule 22), role-plays, and quizzes; virtual/hybrid options for accessibility

Customization and Certification

Tailor to roles (e.g., nurse-focused on phlebotomy ethics); issue DCGI-recognized certificates valid for 3 years, with refresher modules annually.

Evaluation and Follow-Up

Pre/post-assessments (target 80% pass rate); provide toolkits (SOP templates, checklists) and 3-month audits to measure impact.